SOURCE: Xtalks

Xtalks Webinars

October 24, 2017 07:00 ET

A Vast Unmet Need: Challenges in Alzheimer's Clinical Trials, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - October 24, 2017) - In a live broadcast upcoming on Tuesday, November 14, 2017, experts from Premier Research Krista Armstrong, Vice President & Head of Neuroscience and Sebastian Turek, Project Director will review the current global pipeline of Alzheimer's trials and their geographic locations, describe innovations in trial design, and promote consideration of optimal clinical trial processes, including preclinical patient populations, clinical assessments sensitive to the earliest disease-related changes, and biomarkers as outcomes of clinical trials.

Dementia is a growing global epidemic, affecting nearly 47 million people worldwide. That number is expected to approach 75 million by 2030, when the cost of patient care is forecast to reach $2 trillion. And the trend will only accelerate: By 2050, it's estimated that 115 million will suffer from some form of dementia. Alzheimer's disease is by far the most common of these afflictions occurring late in life, making it imperative that we develop new pharmacologic therapies.

More than three decades ago, the cholinergic hypothesis proposed that degeneration of cholinergic neurons in the basal forebrain -- and the associated loss of cholinergic neurotransmission in the cerebral cortex, hippocampus, and other areas -- contributed significantly to cognitive deterioration in Alzheimer's disease. That hypothesis led to development and FDA approval of the first Alzheimer's drug, tacrine, in 1993.

Despite clinical trials of numerous agents over a wide range of mechanisms that include neurotransmitter modulation and disease-modifying therapy targeting amyloid and tau, the last new Alzheimer's medication, memantine, was approved in 2003. The only path to regulatory approval for treatments is well-conducted clinical trials, and trial failures may result from inadequate understanding of mechanisms of action and/or poor target engagement, inadequate study design, the stage of the disease along the continuum studied, inclusion of participants without Alzheimer's pathology in clinical trials, and limited power of endpoint measures.

There are currently 23 drugs in Phase II and III trials targeting amyloid protein buildup in the brain, while 28 drugs are targeting neurotransmitter activity. Twenty-seven Alzheimer's drugs in Phase III clinical trials and eight drugs in Phase II trials may launch in the next five years, according to the Alzheimer's pipeline analysis presented at the Alzheimer's Association International Conference in July 2017. Preventing or delaying disease onset, slowing progression, and improving the symptoms of this disorder are critically important.

Alzheimer's drug development is costly, time-consuming, and inefficient. Site functions, trial design, and patient recruitment all require improvement. At 99.6 percent, the trial failure rate is the highest of any therapeutic area. Innovation is critical to shortening the development cycle of new therapies and identifying drugs that have limited or no therapeutic potential.

To learn more or register for this complimentary session visit: A Vast Unmet Need: Challenges in Alzheimer's Clinical Trials

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, oncology, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit: premier-research.com

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

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